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Pipeline Report 3RD QUARTER 2018 PIPELINE REPORT Be “in the know”. Confidio is committed to helping clients anticipate pharmaceutical trends and potential shifts in medication cost management. Confidio remains informed of the latest FDA drug approvals, medications in development, and upcoming specialty/biosimilar pipeline therapies. Confidio delivers client solutions that are meaningful, measurable, and sustainable. Look for these Drug Pipeline Reports each quarter. PIPELINE AT A GLANCE Recent Approvals • Epidiolex (cannabidiol) – Treats severe, early-onset, treatment-resistant epilepsy syndromes. • Retacrit (epoetin alfa-epbx) – Biosimilar to Epogen/Procrit (epoetin alfa) to treat anemia caused by chemotherapy, kidney disease anemia, and HIV medication (AZT). • Lucemyra (lofexidine hydrochloride) – Approved under the Priority Review process. Used to reduce the severity of opiate withdrawal symptoms in adults. • Tavalisse (fostamatinib disodium) – New 2nd line medication for chronic thrombocytopenia blood disorder (platelet disorder) where limited effective treatment options exist. • Aimovig (erenumab-aooe) – A new biologic indicated for the preventive treatment of migraine headaches in adults. • Plenvu – A low volume bowel prep indicated for cleansing of the colon prior to a colonoscopy. • Olumiant (baricitinib) – Treatment of moderate to severe RA with an inadequate response to one or more tissue necrosis factors (Enbrel®, Humira®, Simponi®, Cimzia®, Remicade®). Anticipated FDA Approvals • Ibalizumab – Biweekly biologic injectable treatment for multidrug resistant HIV. • Translarna (ataluren) – First-in-class oral indicated to treat the underlying cause of Duchenne muscular dystrophy, Previous new treatments targeted the specific nerve dysfunction. • Inotersen – Under Priority Review. Prevention of hereditary TTR Amyloidosis. Currently no or limited effective treatment options. Anticipated Biosimilars FDA Review • Biosimilar to Rituxan® (rituximab) for treatment of cancer, rheumatoid arthritis, and polyangiitis. • Biosimilar to Herceptin® (trastuzumab) for treatment of HER2 adjuvant breast cancer, metastatic breast cancer, and metastatic gastric cancer. 3RD QUARTER 2018 PIPELINE REPORT Recent FDA Approvals Existing FDA Disease or Approval Estimated Drug Name / Treatment Approved Administration Clinical Comments Date AWP / Unit Manufacturer Indication Treatment within Comments Therapy Class 06/25/2018 Pending Epidiolex Seizure: Treats severe, Initial dosage once daily Will provide Treatment Options: early-onset, treatment- oral solution treatment options (cannabidiol) › Felbatol resistant epilepsy for resistant epilepsy Epidiolex is purified GW syndromes including conditions where › Sodium valproate extract of plant-derived Pharmaceuticals Dravet syndrome, there are limited or no cannabidiol, one of the › Topiramate Lennox-Gastaut approved treatment active ingredients in the syndrome (LGS), alternatives › Sodium valproate marijuana plant Tuberous Sclerosis › Lamotrigine Complex (TSC) and › Clobazam Infantile Spasms (IS) › Stiripentol Anticipated Coverage: Rx › FDA designated orphan drug 06/01/2018 Pending Olumiant Rheumatoid Arthritis Initial dosage once daily Many biologic therapy Treatment Options: (baricitinib) (RA): Treatment of oral 4mg options available for Xelzanz moderate to severe rheumatoid arthritis Lilly/Incyte Used as monotherapy RA with an inadequate currently on the or in combination with response or intolerance market. Net cost methotrexate to 1 or more tissue will most likely drive necrosis factors (Enbrel, preferred formulary Humira, Simponi, Cimzia, status. Remicade) Anticipated Coverage: Rx 05/17/2018 $6,900 / Aimovig Migraine (CGRP Monthly self- Almovig is the only Preventative AWP per Inhibitors): Indicated administered SubQ prevention drug Treatment Options: (erenumab-aooe) year for the prevention of injection directly targeted Botox, beta Amgen / migraine headaches in to the cause of the Monthly injection and blockers, Novartis adults migraine headache self-administration may calcium channel Anticipated Coverage: Rx improve compliance PBM will most likely blockers, tricyclic and reduce episode implement step antidepressants, frequency therapy or PA criteria anti-seizure drugs requiring trials of Approx. 39 million lower cost preventive Americans suffer from therapies first migraine, 3x more common in women 05/16/2018 Pending Lucemyra Opioid Withdrawal: Initial dose is 3 tablets Lessen severity of FDA granted Priority (lofexidine Indicated in adults to taken four times daily withdrawal symptoms, Review and Fast hydrochloride) reduce the severity during peak withdrawal may not completely Track designations of opioid withdrawal symptoms for up to 14 prevent them but US WorldMeds symptoms to facilitate days Lucemyra will not opioid discontinuation treat the mental Opioid Withdrawal Should not be used health component of Agents: Anticipated Coverage: Rx with drugs that cause addiction drops in blood pressure, › Clonidine pulse or decreased Indicated for use up › Guanfacine gastric motility. to 14 days Potential additive CNS Potential for depressant effects if dangerous drops taken with opioids, in blood pressure if benzodiazepines, taken with opioids alcohol or other sedating substances. 3RD QUARTER 2018 PIPELINE REPORT Recent FDA Approvals (continued) Existing FDA Disease or Approval Estimated Drug Name / Treatment Approved Administration Clinical Comments Date AWP / Unit Manufacturer Indication Treatment within Comments Therapy Class 05/15/2018 Pending Retacrit (epoetin Hematopoietic (Blood): Retacrit is a biosimilar Biosimilars have the › Retacrit is a alfa-epbx) Treatment of anemia to the epoetin alfa potential to improve biosimilar to due to chronic kidney reference products treatment access, Epogen/Procrit. Pfizer disease for patients on Procrit and Epogen increases competition › Biosimilars would dialysis, Zidovudine in and lower costs. Retacrit has been be considered HIV-infected patients, approved as a Biosimilars are not specialty products chemotherapy in cancer biosimilar, not as an generic drugs but because they are patients, and reduction interchangeable product forms of brand biological products of need for blood medications synthesized through Usual initial dose is 50- transfusion in surgery the biotechnology 100 Units/kg SubQ three Retacrit has been Anticipated Coverage: manufacturing times weekly FDA approved but Rx, Medical process the launch date and market availability › Retacrit is not may take years a biosimilar to the long-acting red-blood cell stimulating product Aranesp (darbepoetin alfa) 05/07/2018 Pending Plenvu Colonoscopy Bowel Plenvu is a two-day Advantage of Numerous Prep: Indicated for regimen separated requiring less active bowel cleansing (PEG 3350, cleansing of the colon into two doses that solution (one liter preparations sodium in preparation for are dispensed in three or slightly over one are available. ascorbate, colonoscopy in adults packets to be mixed quart) per dose Tolerability and sodium sulfate, with water compared to other cost are the primary Anticipated Coverage: Rx ascorbic acid, bowel prep products determinants Plenvu is an osmotic NaCl, KCL) that require larger designating a laxative Valeant Pharma volumes (2-3 liters) preferred product. 05/03/2018 Pending Andexxa Bleeding Reversal: Dose is based on which Andexxa received This indication is (coagulation medication (Xarelto, accelerated approval, approved under Indicated for patients factor xa Eliquis) need to be orphan drug status accelerated treated with Zarelto recombinant) reversed and a breakthrough approval based on (rivaroxaban) and Eliquis therapy designation the change from Portola Pharma (apixaban), when reversal Usual dosage 400mg- from the FDA baseline in anti-FXa of anticoagulation 800mg infused IV activity in healthy is needed due to First drug indicated Andexxa is a volunteers life-threatening or to reverse recombinant modified uncontrolled bleeding anticoagulation effects No current human Factor Xa protein of Xarelto and Eliquis alternative exists Anticipated Coverage: to reverse the Medical anticoagulant effects of Xarelto and Eliquis 04/17/2018 $11,340 / 30 Tavalisse Immunosuppressants: Tavalisse prevents Tavalisse will provide a Treatment Options: (fostamatinib Treatment of chronic platelet destruction new treatment option day › Steroids disodium) and persistent immune in immune for a condition where thrombocytopenia (ITP) thrombocytopenia there are limited › Splenectomy Rigel Pharma in adults when other effective treatment Initial dose is 100 mg › Approx. 24 / therapies have failed options orally twice daily; may 100,000 patients May become first line increase dose if platelet Patients have varying suffer from ITP in treatment for Chronic count has not increased degrees of treatment the US ITP after 1 month response and many › Total US do not respond to Anticipated Coverage: Rx prevalence is 65,000 existing therapy 3RD QUARTER 2018 PIPELINE REPORT Recent FDA Approvals (continued) Existing FDA Disease or Approval Estimated Drug Name / Treatment Approved Administration Clinical Comments Date AWP / Unit Manufacturer Indication Treatment within Comments Therapy Class 04/17/2018 $4,080/ AWP Crysvita Vit-D Deficiency Adult Dose: 1mg/kg First FDA-approved XLH unit (burosumab- Rickets X-linked SubQ monthly medication for Hypophosphatemia Hypophosphatemia the treatment of Agents: 1 Month twza) Pediatric Dose: 0.8 mg/ (XLH): this rare form of Therapy kg SubQ biweekly › Phosphate Ultragenyx Rickets affecting
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